Stent delivery system having stent securement apparatus

ABSTRACT

Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an elongate shaft including a first tubular member and a second tubular member. A balloon may be coupled to the shaft. A first member may be coupled to the first tubular member and positioned within the balloon. A second member may be coupled to the first tubular member and positioned within the balloon. A medical implant may be coupled to the shaft and positioned adjacent to the balloon.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. Ser. No. 12/715,016,filed Mar. 1, 2010; which is a continuation of U.S. Ser. No. 10/737,497,filed Dec. 16, 2003 and issued as U.S. Pat. No. 7,670,364; which is acontinuation of U.S. Ser. No. 09/794,648, filed Feb. 27, 2001 and issuedas U.S. Pat. No. 6,663,660; which is a continuation of U.S. Ser. No.09/418,277, filed Oct. 14, 1999 and issued as U.S. Pat. No. 6,203,558;which is a continuation of U.S. Ser. No. 08/916,554, filed Aug. 22, 1997and issued as U.S. Pat. No. 5,968,069; which is a Continuation-in partapplication based on U.S. Ser. No. 08/807,791, filed Feb. 28, 1997 andissued as U.S. Pat. No. 6,077,273, U.S. Ser. No. 08/701,979, filed Aug.23, 1996 and issued as U.S. Pat. No. 6,395,008, U.S. Ser. No.08/697,453, filed Aug. 23, 1996 abandoned, and U.S. Ser. No. 08/702,150,filed Aug. 23, 1996 and issued as U.S. Pat. No. 6,007,543; all of whichare incorporated by reference in their entirety.

FIELD OF THE INVENTION

This invention relates to an assembly and method for delivering anddeploying an inflation expandable stent, particularly within a lumen ofa body vessel. More specifically, this invention relates to stentsecurement devices most notably positioned between the balloon and theinner shaft of the catheter.

BACKGROUND OF THE INVENTION

Stents and stent delivery assemblies are utilized in a number of medicalprocedures and situations, and as such their structure and function arewell-known. A stent is a general cylindrical prosthesis introduced via acatheter into a lumen of a body vessel in a configuration having agenerally reduced diameter and then expanded to the diameter of thevessel. In its expanded configuration, the stent supports and reinforcesthe vessel walls while maintaining the vessel in an open, unobstructedcondition.

Both self-expanding and inflation expandable stents are well-known andwidely available. Self-expanding stents must be maintained underpositive external pressure in order to maintain their reduced diameterconfiguration during delivery of the stent to its deployment site.Inflation expandable stents (also known as balloon expandable stents)are crimped to their reduced diameter about the delivery catheter,positioned at the deployment site, and then expanded to the vessel bydiameter by fluid inflation of the balloon positioned between the stentand the delivery catheter. The present invention is particularlyconcerned with enhanced stent securement and safer stent loading in thedelivery and deployment of balloon expandable stents.

In angioplasty procedure, there may be restenosis of the artery, whicheither necessitates another angioplasty procedure, a surgical bi-passprocedure, or some method of repairing or strengthening the area. Toprevent restenosis and strengthen the area, a physician can implant anintravascular prosthesis for maintaining vascular patency, i.e. a stent,inside the artery at the lesion. The stent is expanded to a largerdiameter for placement in the vasculature, often by the balloon portionof the catheter. Stents delivered to a restricted coronary artery,expanded to a larger diameter as by a balloon catheter, and left inplace in the artery at the site of a dilated lesion are shown in U.S.Pat. No. 4,740,207 to Kreamer; U.S. Pat. No. 5,007,926 to Derbyshire;U.S. Pat. No. 4,733,665 to Palmaz; U.S. Pat. No. 5,026,377 to Burton etal; U.S. Pat. No. 5,158,548 to Lau et al; U.S. Pat. No. 5,242,399 to Lauet al; U.S. Pat. No. 5,344,426 to Lau et al; U.S. Pat. No. 5,415,664 toPinchuck; U.S. Pat. No. 5,453,090 to Martinez et al; U.S. Pat. No.4,950,227 to Savin; U.S. Pat. No. 5,403,341 to Solar; U.S. Pat. No.5,108,416 to Ryan et al; and European Patent Application No. 707837A1 toScheiban, all of which are incorporated herein by reference. A stentparticularly preferred for use with this invention is described in PCTApplication No. 96/03092-A1, published 8 Feb. 1996, the content of whichis incorporated herein by reference.

In advancing a balloon expandable stent through a body vessel to thedeployment site, there are a number of important considerations. Thestent must be able to securely maintain its axial position on thedelivery catheter. The stent, particularly its distal and proximal ends,are sometimes protected to prevent distortion of the stent, and minimizetrauma to the vessel walls. Balloon expandable stent delivery anddeployment assemblies are known which utilize restraining means thatoverlay the stent during delivery. U.S. Pat. No. 4,950,227 to Savin etal, relates to a balloon expandable stent delivery system in which asleeve overlaps the distal or proximal margin (or both) of the stentduring delivery. During inflation of the stent at the deployment site,the stent margins are freed of the protective sleeve(s) and the sleevesthen collapse toward the delivery catheter for removal. A number ofballoon expandable stent delivery and deployment assemblies do not useoverlaying restraining members, such as the Savin sleeves, to positionthe stent for delivery. European Patent Application No. EP 055 3960A1 toLau et al, uses an elastic sheath interspaced between the balloon andthe stent. The sheath is said to act as a barrier to protect the balloonfrom the stent, allow uniform stent expansion, decrease balloondeflation time, prevent undesirable balloon flattening upon deflationand provide a friction substrate for the stent. The Lau sheath can bepositioned on the inside or outside of the balloon. U.S. Pat. No.5,409,495 to Osborne, similarly uses an elastic sleeve or sheathsurrounding and in contact with the balloon for controlling the balloonradial expansion. In addition, Osborne is said to use restraining bandsor a pair of balloons to achieve controllable stent expansioncharacteristics. U.S. Pat. No. 5,403,341 to Solar, relates to stentdelivery and deployment assembly which uses a retaining sheathpositioned about opposite ends of the compressed state. The retainingsheaths of Solar are adapted to tear under pressure as the stent isradially expanded, thus releasing the steno for engagement with thesheaths. U.S. Pat. No. 5,108,416 to Ryan et al. describes a stentintroducer system which uses one or two flexible end caps and annularsocket surrounding the balloon to position the stent during introductionto the deployment site. The content of all of these patents isincorporated herein by reference.

In positioning a balloon expandable stent on the delivery catheter overthe fluid expandable balloon, the stent must be smoothly and evenlycrimped to closely conform to the overall profile of the catheter andthe unexpanded balloon. It has been noted that, due to physicalproperties of the material used in manufacturing the stent (typically ashaped memory metal, such as stainless steel or Nitinol™) there is acertain amount of “recoil” of the stent despite the most careful andfirm crimping. That is the stent evidences a tendency to slightly openup from the fully crimped position and once the crimping force has beenreleased. For example, in the typical stent delivery and deploymentassembly, if the stent has been fully crimped to a diameter ofapproximately 0.0035″, the stent has been observed to open up or recoilto approximately 0.0037″. This phenomenon has been characterized as“recoil crimping”. Due to recoil crimping to this slightly enlargeddiameter, it can be understood that the stent tends to evidence acertain amount of looseness from its desired close adherence to theoverall profile of the underlying catheter and balloon. That is, thestent tends to have a perceptible relatively slack fit in its mountedand crimped position. During delivery, the stent can thus tend to slipand dislocate from its desired position on the catheter or even becomeseparate from the catheter, requiring further intervention by thephysician.

According to the present invention, a securement device is secured overthe inner catheter beneath the balloon to compensate for the undesiredlooseness or slack that due to recoil crimping and to aid in securingthe stent to the balloon, as well as protecting the balloon materialfrom being sandwiched between the stent and any metal or protruding itemwhich may be mounted on the inner shaft/guide wire lumen, for deliveryof the stent. The securement devices secure the stent during trackingand delivery and provide a good friction fit to the stent and insuregood contact between the stent and underlying balloon and catheter,instead of merely crimping the stent onto the balloon and the underlyingcatheter and relying on the bulk of the flaccid balloon to hold thestent on.

The art referred to and/or described above is not intended to constitutean admission that any patent, publication or other information referredto herein is “prior art” with respect to this invention. In addition,this section should not be construed to mean that a search has been madeor that no other pertinent information as defined in 37 C.F.R. §1.56(a)exists.

SUMMARY OF THE INVENTION

This invention concerns a catheter apparatus suitable for performingangioplasty and for delivery of stents to body cavities. In general,stents are prosthetic devices which can be positioned within a bodycavity, for example, a blood vessel or in some other difficultlyaccessible place of the body of a living human or animal. The stentprosthesis is formed of a generally tubular body, the diameter of whichcan be decreased or increased. Stents are particularly useful forpermanently widening a vessel which is either in a narrowed state, orinternally supporting a vessel damaged by an aneurysm. Such stents aretypically introduced into the body cavity by use of a catheter. Thecatheter is usually of the balloon catheter type in which the balloon isutilized to expand the stent, which is positioned over the balloon fordelivery, to place it in a selected location in the body cavity. Thepresent invention is particularly directed to improved arrangements forreleasably attaching and securing the stent to the catheter tofacilitate delivery thereof, specifically having a securement devicewithin the balloon. The below identified embodiments all discloseimproved means for securing the stent to the catheter during thedelivery procedure.

In certain embodiments the stent is held in place on the catheter bymeans of an enlarged mounting body carried within the balloon by thecatheter shaft to which the stent and balloon are fitted. The stent isfitted over the balloon, as by crimping. According to the invention insome embodiments, the enlarged body is axially movable on the innershaft of the catheter so that it can be retracted from the stentmounting area to provide a small profile for performing angioplasty. Thecatheter can then be withdrawn; the enlarged body can be moved into thestent mounting area; the stent can be mounted and the catheter can bere-inserted to implant the stent. In other embodiments, the enlargedbody can be arranged to be reducible and enlargeable in size rather thanbeing movable. Alternatively, the movable mounting body may be carriedoutside the balloon. A catheter of this type makes possible a method inwhich, before stent loading with the associated mounting body arrangedto provide reduced diameter in the balloon region, the catheter may beused to dilate a lesion or the like. The catheter may be withdrawn andthe mounting body may then be selectively manipulated to provide anenlarged diameter in the stent mounting region and a stent may be loadedonto the catheter. The catheter may be re-inserted to implant the stent.The catheter may be withdrawn or left in situ and the mounting body maybe manipulated to provide reduced diameter again and the catheter may beused for any post-dilation desired. Also, the catheter may be usedmultiple times in the procedure for dilation and stent implantation.

Another embodiment of the present invention is also an assembly fordelivery and deployment of an inflation expandable stent within avessel. The assembly comprises a catheter, an expandable tube componentmounted on the catheter, an expandable balloon mounted on the catheterand encompassing the tube component, and a stent mounted on the balloon.The catheter has proximal and distal ends. The stent is inflationexpandable from a delivery diameter to a deployment diameter. Thedelivery diameter is reduced from the deployment diameter for conformingthe stent to the catheter. The stent, in its delivery diameter, iscoaxially mounted on the catheter near the catheter distal end. Theexpandable balloon is coaxially mounted on the catheter axially withinthe stent. The balloon is designed and adapted for expansion of thestent from the delivery diameter to the deployment diameter uponapplication of fluid deployment pressure to the balloon. The expandabletube component is coaxially mounted on the catheter, axially within theexpandable balloon. The tube components is designed and adapted forfluid expansion to provide a securement pressure to the stent in thedelivery diameter to maintain the stent in position on the catheterduring delivery to the deployment site. The expandable tube component issized and constructed to be fluid expandable to no more than thedelivery diameter. The tube component is essentially equal in length tothe stent and the stent is positioned on the assembly essentiallycoextensive with the tube component.

In another embodiment, this invention is a method for delivering anddeploying a stent using an assembly as just described. A catheter isprovided having proximal and distal ends. An expandable balloon iscoaxially mounted on the catheter. An expandable tube component iscoaxially mounted on the catheter, axially within the expandableballoon. The balloon and the tube component are each in an unexpandedcondition. A stent is provided which is expandable from a deliverydiameter to a deployment diameter. The stent, in a diameter greater thanthe delivery diameter, is mounted on the balloon. The stent is collapsedto the delivery diameter to conform to an overall profile of thecatheter, the tube component and the balloon. The tube component isinflated to provide to the stent a securement pressure, to retain thestent on the assembly in the delivery diameter. The assembly isdelivered to a deployment site. The balloon is inflated to expand thestent to its deployment diameter.

An alternative embodiment of present invention is also an assembly fordelivery and deployment of an inflation expandable stent within avessel. The assembly comprises a catheter, an expandable balloon mountedon the catheter, a corrugated tubing mounted on the catheter beneath orwithin the balloon, and a stent mounted on the balloon. The catheter hasproximal and distal ends. The stent is inflation expandable from adelivery diameter to a deployment diameter. The delivery diameter isreduced from the deployment diameter for conforming the stent to thecatheter. The stent, in its delivery diameter, is coaxially mounted onthe catheter near the catheter distal end. The expandable balloon iscoaxially mounted on the catheter axially within the stent. The balloonis designed and adapted for expansion of the stent from the deliverydiameter to the deployment diameter upon application of fluid deploymentpressure to the balloon. The corrugated tubing is mounted and adheredcoaxially onto the catheter and is situated between the balloon and thecatheter itself. When the stent is crimped and loaded onto the balloon,the balloon is situated therefore between the stent and the corrugatedtubing. The tubing is preferably essentially equal to the length of thestent and the stent is positioned on the assembly essentiallyco-extensive with the tube component. The tubing on the cathetereffectively holds the stent in place, takes up the slack due to recoiland protects the balloon material from being damaged during crimping.

Still another embodiment of the present invention comprises an assemblyfor delivery and deployment of an inflation expandable stent. Theassembly comprises a catheter having proximal and distal ends. Anannular collar or the like is coaxially located on the catheter distalend. A fluid expandable balloon is coaxially mounted over the collar atthe catheter distal end. The balloon is expandable from a contracted toan expanded state. A stent is coaxially mounted on the balloon. Thestent is inflation expandable from a reduced to an enlarged condition,the reduced condition conforming the stent to the balloon, collar andcatheter in the preferred embodiment. The stent has at least an endportion overlying the balloon. At least one cup is coaxially mounted onthe catheter distal end. The cup has a first end portion which mayoverlie the stent end portion. The cup and collar are cooperativelyconstructed and arranged to retain the stent end portion on the catheterin the stent reduced condition when the balloon is in the contractedstate. The balloon and catheter are cooperatively constructed andarranged to cause expansion of the balloon from the contracted to theexpanded state to cause enlargement of the stent, including the stentend portion, from the reduced to the enlarged condition, and therebyrelease the stent end portion from the cup end portion. The cup may beaxially spaced from the collar but preferably they are relatively closetogether. The second end portion of the cup may be fixed to thecatheter. The cup may overlie at least a portion of the collar. Thecollar can be shaped as a single member with the catheter, that isintegral with it or the collar may be a separate body mounted axiallyand positioned on the catheter. The collar may be a mounting ring orcylinder axially positioned between stent end portions under the stentand balloon. The collar may be a sheath under the stent and balloon.

A further embodiment is also directed to improved arrangements forreleasably attaching the stent to the catheter to facilitate deliverythereof. The stent is held in place on the catheter by means of anenlarged body carried by the catheter shaft within the balloon to whichthe stent and balloon are fitted, as by crimping in combination with oneor more sleeves releasably overlying an end portion or portions of astent and balloon.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is an isometric view, a portion of which is enlarged and inlongitudinal section, of a balloon catheter having a mounting body in aretracted position;

FIG. 2 is an even more enlarged view in longitudinal cross-section ofthe distal end portion of the catheter of FIG. 1;

FIG. 3 is similar to FIG. 2 but showing the mounting body advanced toreceive a stent mounted on the balloon;

FIG. 4 is an enlarged cross-sectional view of the distal end portion ofthe catheter of FIG. 1 similar to that of enlarged view FIG. 3 butshowing the balloon in an expanded condition along with the expandedstent;

FIG. 5 is a schematic showing of a preferred mounting body carried bythe catheter shaft within the balloon, the body being spirally cut toimprove flexibility;

FIG. 6 is a schematic showing in cross-section of another embodiment ofthe invention with a mounting body positioned to receive a stent butwith a stent not yet mounted;

FIG. 7 is a schematic showing of another embodiment of the invention;

FIG. 8 is a schematic showing of a means for conveniently crimping thestent on the embodiment shown in FIG. 5;

FIG. 9 is a schematic showing of yet another embodiment of theinvention;

FIG. 10 is a showing of another embodiment of a mounting body accordingto the invention;

FIG. 11 is a schematic of an enlargeable mounting body which is notaxially movable;

FIG. 12 is a schematic of an alternate enlargeable mounting arrangementwhich is not axially movable;

FIGS. 13 and 14 are schematic showings of yet another embodiment inwhich the axially movable mounting body is carried outside the balloon;

FIGS. 15 and 16 are schematic showings of still yet another embodimentof the invention, and

FIGS. 17 and 18 are modified versions of the embodiment shown in FIG.11.

FIGS. 19-21 are modified versions of the securement means of the presentinvention.

FIG. 22 is a side profile section showing a balloon expandable stentdelivery and deployment assembly, with the stent crimped to deliverydiameter onto the balloon, the underlying inflating component and thecatheter and with the inflating tube component inflated to securementpressure.

FIG. 23 is a side profile section, similar to FIG. 22, with the balloonand the stent fully inflated to deployment diameter.

FIG. 24 is a side profile section showing an alternative embodiment of aballoon expandable stent delivery and deployment assembly, having a tubecomponent formed in several sections.

FIGS. 25, 26 and 27 are cross-sectional views taken along lines 4-4, 5-5and 6-6 of FIG. 24, respectively.

FIG. 28 is a side profile section showing a balloon expandable stentdelivery and deployment assembly, with the stent crimped to deliverydiameter onto the balloon, the underlying tube component and thecatheter.

FIG. 29 is a side profile section, similar to FIG. 28, with the balloonand the stent fully inflated to deployment diameter.

FIG. 30 is a perspective view of the corrugated tubing of the presentinvention.

FIGS. 31-33 are side profile sections showing alternative embodiments ofballoon expandable stent delivery and deployment assemblies, having thetubing component formed in a plurality of sections.

FIGS. 34-35 are side profile sections showing alternative embodiments ofthe balloon expandable stent delivery and deployment assemblies, thetube component inflatable to add securement pressure.

FIG. 36 is a side profile section showing a balloon expandable stentdelivery and deployment assembly, with the stent crimped to deliverydiameter onto the balloon, the underlying tube component and thecatheter, and also having containment sleeves covering the ends of thestent.

FIG. 37 is a side profile section showing a balloon expandable stentdelivery and deployment assembly, with the stent crimped to deliverydiameter onto the balloon, the underlying tube component and thecatheter, and also having a pull-back wire attached to the tubecomponent.

FIG. 38 is a longitudinal cross-section of a stent delivery anddeployment assembly of this invention showing a catheter with a collarmounted at the catheter distal end, an uninflated balloon mounted on thecatheter over the collar, an unexpanded stent mounted on the balloonabutting the collar and a cup overlying the stent proximal end portion.

FIG. 39 is a longitudinal cross-section of another stent delivery anddeployment assembly of this invention showing a catheter with a collarmounted as a mounting ring at the catheter distal end, an uninflatedballoon mounted on the catheter over the mounting ring, an unexpandedstent mounted on the balloon overlying the mounting ring and a cupoverlying the stent proximal end portion; note that the collar ispositioned closer to the cup than in FIG. 38.

FIG. 40 is a longitudinal profile in partial cross-section of anassembly similar to that of FIG. 38, with a bulge formed under theuninflated balloon at the catheter distal end.

FIG. 41 is a longitudinal profile in partial cross-section of theassembly shown in FIG. 38 with the balloon inflated and the stentexpanded, showing the cup end portion flared to release the stent.

FIG. 42 is a longitudinal profile, similar to FIG. 41, showing the cupend portion rolled proximally to release the stent.

FIG. 43 is a longitudinal profile of yet another stent delivery anddeployment assembly of this invention, with the balloon mounted on thecatheter, which has a collar formed as a tapered single enlarged pieceon the catheter, an unexpanded stent mounted on the unexpanded balloonabutting the collar and a cylindrical sleeve overlying the stentproximal end portion.

FIG. 44 is a longitudinal profile of the assembly of FIG. 43 with theballoon inflated and the stent expanded, showing the sleeve movedproximally to release the stent.

FIG. 45 is a side profile of still another stent delivery and deploymentassembly of this invention with the uninflated balloon mounted on thecatheter which has two collars formed integrally with the catheter, anunexpanded stent mounted on the balloon abutting the collar and acylindrical cup overlying the stent proximal end portion and theunderlying collar.

FIG. 46 is a longitudinal profile of another stent delivery anddeployment assembly of this invention with the uninflated balloonmounted on the catheter, an unexpanded stent mounted on the balloon,mounting a cylinder on the catheter and a pair of cups overlying thestent ends.

FIG. 47 is an isometric view, a portion of which is enlarged and inlongitudinal section, of a balloon catheter having a stent fixed to thecatheter over the balloon;

FIG. 48 is an even more enlarged view in longitudinal cross-section ofthe distal end portion of the catheter of FIG. 47;

FIG. 49 is a schematic showing of one form of retraction of thereleasable sleeve upon expansion of the balloon;

FIG. 50 is a schematic showing of another form of retraction of thereleasable sleeve upon expansion of the balloon;

FIG. 51 is yet another form of retraction of the releasable sleeve uponexpansion of the balloon;

FIG. 52 is a schematic showing of yet another form of retraction of thereleasable sleeve upon expansion of the balloon;

FIG. 53 is a schematic showing of a modified shape for the releasablesleeve;

FIG. 54 is a schematic showing in cross-section of another embodiment ofthe invention with a stent not yet mounted;

FIG. 55 is a schematic showing of another embodiment of the invention;and

FIG. 56 is a schematic showing of yet another embodiment of theinvention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to stent securement devices, most notablypositioned between the balloon and the inner shaft of the catheter.Individual elements of the below disclosed embodiments are generallyinterchangeable if desired. Referring to FIGS. 1-4 an angioplasty andstent delivery catheter system generally indicated at 10 includes aballoon catheter 12 having a balloon 14 on a distal end portiongenerally indicated at 16. FIG. 1 shows a proximal portion of thecatheter at 12 a and a distal portion 12 b in enlarged view. FIGS. 2 and3 show the distal end portion 16 in an even more enlarged view. Theillustrative catheter 12 is of the type known as a rapid exchange orsingle operator catheter. However, other types of catheters may be used,such as over the wire and fixed wire types. The balloon 14 is fixed tothe catheter 12 by standard means. The balloon is shown in itscontracted state in. A stent 18 is fixed about the balloon by crimpingthereto. The stent has a larger expanded diameter which is obtained whenthe balloon is expanded in the known manner. In FIGS. 1 and 2 catheteris shown prepared for performing angioplasty and in FIG. 3 it isprepared for stent implantation.

In FIGS. 1 and 2, an axially movable mounting body 30 is shown in aposition proximal to the end portion 16 of the catheter where a stentmay be mounted. The catheter includes at its proximal end a manifold,generally designated 13, as is known in the art. The manifold includesan inflation port 15 as is known in the art. A wire 31 is attached tobody 30 to enable remote (from the proximal catheter end) advancementand retraction of it axially on inner lumen 26 over which it slides. Inthe retracted position shown in FIGS. 1 and 2, the catheter has a lowprofile for performing angioplasty.

This position is a refracted position and is selected by operation of apull wire 31. The retracted position of the mounting body may vary. Tomaximize the low profile of the distal end 16 of the catheter, theretracted position may be within the outer member 24.

After such a procedure, the balloon is deflated, the catheter iswithdrawn and the mounting body is advanced by means of wire 31 to thestent mounting position shown in FIG. 3. A stent 18 may then be fixedabout the deflated balloon by crimping it thereto. The stent has alarger expanded diameter which is obtained when the balloon is againexpanded in the known manner. That is, the stent is released from thecatheter upon expansion of the balloon as shown in FIG. 4 to be placedin a vessel at the desired location. When the balloon is then againdeflated, removal of the balloon and catheter may be accomplished,leaving the stent in place. Exemplary dimensions for the inner 26 is adiameter of ½ mm and for body 30 a diameter of ¾ mm.

As is known in the art the balloon is either bonded at its ends byadhesive 20 and 22, respectively to the outer member 24 of the catheterand to the inner member 26 of the catheter in the manner as shown, or ismade one-piece with the outer member as is known in the art. Thecatheter balloon may be inflated by fluid (gas or liquid) from aninflation port extending from a lumen 28 (seen in FIGS. 2 and 3)contained in the catheter shaft and opening into the balloon as shown,or by other known arrangements, depending on the design of the catheter.The details and mechanics of balloon inflation and specific overallcatheter construction will vary according to the particular designinvolved in any given instance, and are known in the art per se. Suchdetails are only shown schematically herein. All variations areacceptable for use with this invention.

Any balloon expandable stent may be used with this invention. Many areknown in the art including plastic and metal stents. Some are more wellknown such as the stainless steel stent shown in U.S. Pat. No.4,735,665; the wire stent shown in U.S. Pat. No. 4,950,227; anothermetal stent shown in European Patent Application EPO 707 837 A1 and thatshown in U.S. Pat. No. 5,445,646, or U.S. Pat. No. 5,242,451. All ofthese patents are incorporated herein by reference. Also, shape memorymetal stents may be used. As already indicated the stent of PCTApplication 960 3092 A1 is particularly preferred.

The stent is typically for example about 16 mm long, while the balloonmay be 20 mm long for example. These dimensions, however, are merelyrepresentative for illustrative purposes only and are not meant to belimiting. The stent is positioned over the balloon portion of thedilatation catheter and gently crimped onto the balloon either by handor with a tool such as a pliers or the like to be mounted for deliveryas shown in FIG. 3. The crimping may be readily accomplished by thephysician during the procedure.

In accordance with this invention, mounting body 30, best seen in FIGS.2 and 3, is included inside balloon 14 to provide a cushion and/orsubstrate of enlarged diameter relative to the stent to support and holdthe stent and secure it during crimping and the delivery procedure. Themounting body may be axially movable proximally or distally from theposition shown in FIG. 3, proximally being preferred.

In the embodiment shown in FIGS. 1-3, mounting body 30 is cylindrical inform and takes the shape of a sleeve axially and slidably carried oninner lumen 26, providing an enlarged area or portion for receiving theballoon and stent when the latter is crimped to the balloon. Marker band34 may also be included on inner 26 as shown. Any radiopaque materialsuch as gold is useful for this purpose. A stop member 36 of generallyconical shape or any other shape may also be included on the marker band34 as shown to provide additional resistance to stent movement duringdelivery and to protect the leading edge of the stent during delivery.Polyethylene or the like is suitable for the stop member. Other markerarrangements and stop arrangements may be used as well.

Although, the material of the mounting body may be hard, it ispreferably of any deformable thermoplastic material, preferably anelastomer material and more preferably of a relatively resilientelastomer material, e.g., lower durometer silicone. A preferreddeformable thermoplastic material is high density polyethylene (HDPE). Apreferred lower durometer silicone is in the form of tubing. Thedeformation of the resilient material of the mounting body when thestent/balloon is crimped to it causes a radial outward force on thestent/balloon increasing the friction therebetween despite any recoil ofthe stent.

During stent delivery, the balloon catheter is advanced through andpositioned in a patient's vasculature so that the stent is adjacent tothe portion of the vessel where treatment is to take place. The balloonis inflated to expand the stent to an enlarged diameter. When the stenthas reached the desired diameter, the balloon is deflated so that thecatheter may be removed leaving the stent in place.

Another embodiment of the invention is shown in FIG. 5. In thisembodiment mounting body 30 is a spiral cut elastomer or other suitablematerial, such as a rigid or flexible plastic, to provide separation forflexibility in that portion of the catheter, allowing more easy movementor tracking around bends. The spiral cut may be only partly through themounting body or may be all the way through as shown in FIG. 5. Also,while stop member 36 is shown at the distal end portion of the catheterin this embodiment, no stop member may be used.

Another similar version is shown in FIG. 6 which includes a cylindricalmounting body 30 made up of a plurality of separate adjacent rings 30 aheld together by wire 31 which extends therethrough as shown with stops29 to secure the rings together. Rings 30 a may be individual bodiescarried on the sheath or bodies cut from a cylinder to partiallyseparate them or fully separate them. Suitable arrangements may be madeto wire 31 at each end of the body 30 to hold the rings together, asshown.

The embodiment shown in FIG. 7 includes another feature based on thegeometry of the mounting body for further securing the stent uponcrimping. This feature is referred to herein as “interlocking” That is,the stent may be interlocked to the mount so that the stent cannot slideproximally or distally on the balloon unless it is deformed, such as byexpansion. This can be seen by perusing the structure shown in FIG. 7which includes the inner 26 having a two-piece mounting body made up ofspaced mounting bodies 30 a and 30 b. These bodies are connected to eachother by connection means 33 which may be a separate or integralcylindrical body of lesser diameter or may be one or two or morerelatively rigid wire members as shown. The spacing between bodies 30 aand 30 b allows portions of the stent 18 and balloon 14 to be depressedor inserted between the bodies upon crimping of the stent thus formingan interlock against sliding of the stent axially or longitudinallybefore the stent is released.

The interlock formation or crimping is readily accomplished by anysuitable means such as a two-piece die 40 shown in FIG. 8 or the like.

FIG. 9 demonstrates that more than a two-piece mounting body arrangementmay be used if desired. In this embodiment, the mounting body iscomprised of three spaced interconnected bodies 30 a, 30 b and 30 c onthe inner 26. Preferably in the embodiments of FIGS. 7 and 9, themounting bodies will be ring-like in shape or cylindrical in shapealthough other configurations will be readily apparent to those familiarwith this art.

Referring now to FIG. 10, another embodiment of a movable mounting body30 is shown in the form of a rigid coil of plastic, metal or the likehaving a control wire 31, preferably integral therewith. When in themetal form, the coil may be coated with a polymer such as polyethyleneor PTFE or enclosed in a polymeric sheath of similar material. The coilmay be slidably received on the inner 26 similar in arrangement to thatshown in the preceding Figures.

As already indicated, an alternate arrangement may be used in which themounting body, instead of being movable, is designed to be enlargeableand reducible or collapsible, while remaining in a fixed position in thestent mounting area of the catheter. FIGS. 11 and 12 are directed tosuch an arrangement.

In FIG. 11, an inner balloon 50 of smaller diameter than outer balloon14 is mounted on the inner 26. Balloon 50 may have a separate inflationconduit 52 inside inner 26, preferably including a valving arrangement54. Valve 54 may be a one-way valve allowing only inflation of balloon50 if desired. However, inner 26 may serve as the inflation conduit aswell. In addition to fully inflating the balloon, inner balloon 50 mayalso be partially inflated.

FIG. 19 shows a modification to FIG. 11 in which two inner balloons 50 aand 50 b are included. FIG. 20 shows a modification in which twoinflation valves 54 a and 54 b are included.

FIG. 21 shows a full arrangement of inner balloon 50 in which a syringe120 is inserted into the distal end of the liner 26 of the catheter. Thesyringe has at its ends blocks 122 and 124 to enable localpressurization of inner 26 to inflate balloon 50.

FIGS. 17 and 18 show an inner balloon 50 similar to the arrangement ofFIG. 11 but the balloon 50 in FIG. 17 has a narrow center portion andwide ends to provide a mounting shape similar to that of FIG. 7. In FIG.17, balloon 50 is inflated and balloon 14 is partially inflated. In FIG.18, balloon 50 is inflated and balloon 14 is uninflated ready for stentloading. Balloon material is preferably a polyethylene or urethaneelastomer such as Tecoflex or Tecothane from Thermedics.

Referring to FIG. 12, an alternate embodiment is shown in which theproximal portion of the inner 26 is axially movable while the distalportion 26 b is fixed with respect to the catheter. In between portion26 a and portion 26 b is a coil spring 60 inside a flexible sheath 62 ofPTFE or the like. Portion 26 b of the inner is attached to balloon 14 atthe very distal end portion of the catheter. Portion 26 a is movableaxially within the outer 22. Thus, if 26 a is pushed in the distaldirection and held to compress coil 60, the coil will enlarge indiameter to provide an enlarged mounting area for a stent. Twisting theinner to twist the coil will enhance enlargement. Alternatively, coilspring 60 may be replaced by a braided element.

Also, by providing different pitch over the length of the coil it can bemade to enlarge more in some regions than in others. For example, if thecoil windings are closer together in the center portions than in the endportions, when the coil undergoes compressing, the two end portions willenlarge in diameter more than the center portion to provide a mountsimilar to that of FIG. 7.

Referring now to FIGS. 13 and 14, another embodiment is shown which isalternative to the earlier described embodiments which are inside theballoon on the catheter. In this embodiment a sheath 80 is carried onthe outside of the catheter. Sheath 80 is elastomeric and is axiallymovable from a stent mounting position as shown in FIG. 14 to a positionremote from the stent mounting position, such as the retracted positionas shown in FIG. 13. In the position shown in FIG. 13, balloon 14 may beinflated and deflated. In the position shown in FIG. 14, balloon 14 willbe deflated for low profile. Sheath 80 when over the balloon as in FIG.14 acts to increase the profile of the catheter to facilitate crimping astent thereto during deployment of the stent, sheath 80 will expand withballoon 14 to facilitate inflation and during deflation the elastomersheath will return to its original dimension. An elastomer materialwhich is presently preferred is Tecothane, a trade name for athermoplastic polyurethane available from Thermedics, Inc., of Woburn,Mass. It may be about 0.003 inches thick, for example.

With respect to FIGS. 15 and 16, a further embodiment of the inventionis shown in which inner 26 carries a mounting body 30, the distal end100 of which is secured or fixably attached to inner 26, as by anysuitable adhesive. The remainder of body 30 is slidable over inner 26 asby the application of compression in the distal direction at theproximal end 102. This may be accomplished by push wire 104 whichextends to the proximal end of the catheter for remote manipulation asis known in the art.

Mounting body 30 is accordion folded with more widely spaced folds atthe end portions 106, than at the central portion 108. Thus, as can beseen in FIG. 15, a relatively low profile is provided withoutcompression for normal angioplasty use. When a stent is to be mounted(not shown), compression by means of push wire 104 will result in aconfiguration of enlarged diameter of body 30 as shown in FIG. 16 toprovide a mount similar to that of FIG. 7 in general configuration. Ifthe spring is uniform over the body, it will enlarge uniformly, similarto the inner balloon of FIG. 11. The Figures are schematic in form butthe concept can be readily appreciated.

As an alternative to a folded construction, the body may be of braidedconstruction to achieve the same operation.

Also, this form of body 30 may be inserted into a two piece inner 26similar to the arrangement shown in FIG. 12. In all of thesearrangements, the accordion folded body material may be of any suitablepolymer, such as polyethylene. For example, tubing having a wallthickness of about 0.002 inches may be used. The accordion folds orpleats may be readily formed in such tubing by means of a pressure moldcontaining spaced blades placed in a heated chamber.

FIGS. 22-27 show embodiments wherein the inner securement devicecomprises an inner balloon beneath the outer catheter balloon, similarto above. FIGS. 22 and 23 illustrate a side profile section showing aninflation expandable stent delivery and deployment assembly generallydesignated 110. Assembly 110 includes a catheter comprised of innershafts 112 and 113 and an outer shaft 115 of the coaxial type, aninflation expandable balloon 114, an inflation tube component 116 suchas an inner balloon and inflation expandable stent 118. Any conventionaltype of catheter may be used, such as a catheter of the type generallyused for PTA or PTCA angioplasty procedures, for prostate therapy, andTTS endoscopic catheters for gastrointestinal use. However, coaxialtypes as shown are most preferred. The particular catheter 112 shown isformed of a biocompatible and hydrophilic compatible material, such as alubricous polyimide or polyethylene. Other suitable materials for thecatheter 112 include nylons, urethanes, and polypropylene materialscompatible with coatings such as silicone and/or hydrophilic coatings.In addition to hydrophilic compatible materials, any biocompatiblematerial may be used. For example, polyethylene or polypropylene can becoated with a hydrophilic material to render them hydrophilic compatiblesuitable catheters for use according to the present invention include anumber of catheters available from SciMed Life Systems, Inc., MapleGrove, Minn., the assignee of the present invention, such as BANDI™,COBRA™, VIVA™, and VIVA PRIMO™ catheters.

Inflatable tube component 116 is fixed at its distal and proximal end toinner shaft 112 and at its proximal end to inner shaft 113 at a positionto be encompassed within the distal and proximal ends of the outerballoon 114. According to art-recognized convention, the length L-B ofthe balloon 114 is defined as the length of the body portion of theballoon 114, excluding the terminal cone sections 120. As seen in FIG.23, the body portion of the balloon 114 is generally cylindrical when inits deployed or inflated condition. Tube component 116 is illustrated ashaving terminal sections 122 which are more relatively vertical than thecone sections 120 illustrated for the balloon 114. However, it is to beunderstood that, according to the present invention, either of theterminal sections 120, 122 may be relatively cone shaped, relativelyvertical or of any other configuration known to those of skill in thisart. A preferred length L-T of the tube component 116 is illustrated inFIGS. 22 and 23 as substantially equal to the length L-B of balloon 114,and substantially equal to the length L-S of stent 118. However,according to the present invention, stent 118 should be supported by theunderlying tube component 116 for a length sufficient to permitaccomplishment of the stated purpose of the tube component 116, wheninflated, to provide-securement pressure for stent 118 to maintain stent118 in position with assembly 110 during delivery. It is also within thepresent invention for tube component 116 to be slightly shorter thanstent 118, for example, the distal end 119 of stent 118 may extenddistally beyond the distal end 121 of tube component 116 (not shown), sothat the distal end 119 of stent 121 can be crimped over the distal end121 of tube component 116 to prevent the distal end 119 of stent 118from catching and tending to further open as it is maneuvered within abody vessel. As has been explained above, tube component 116 is designedand constructed to be inflatable to no more than is necessary tocompensate for recoil crimping of stent 118 and to closely accommodate(or even slightly over-stress) the delivery diameter of stent 118,taking into consideration the thickness of the intervening uninflatedballoon 114. Tube component 116 is inflated through the opening(s) 117of inner shaft 112. Typically, tube component 116 will have a wallthickness of about 0.0002-0.0007 inch and will be inflatable to no morethan about 0.035.-0.045 inches.

Inflating tube component 116 may be formed of either compliant ornon-compliant balloon materials. Compliant materials include lowpressure, relatively soft or flexible polymeric materials, such asthermoplastic polymers, thermoplastic elastomers, polyethylene (highdensity, low density, intermediate density, linear low density), variousco-polymers and blends of polyethylene, ionomers, polyesters,polyurethanes, polycarbonates, polyamides, poly-vinyl chloride,acrylonitrile-butadiene-styrene copolymers, polyether-polyestercopolymers, and polyetherpolyamide copolymers. Suitable materialsinclude a copolymer polyolefin material available from E.I. DuPont deNemours and Co. (Wilmington, Del.), under the trade name Surlyn™ Ionomerand a polyether block amide available under the trade name PEBAX.Non-compliant materials include relatively rigid of stiff high pressurepolymeric materials, such as thermoplastic polymers and thermosetpolymeric materials, poly(ethylene terephthalate) (commonly referred toas PET), polyimide, thermoplastic polyimide, polyamides, polyesters,polycarbonates, polyphenylene sulfides, polypropylene and rigidpolyurethanes.

A balloon 114 for use according to the present invention may be anyconventional balloon for catheter delivery, such as a balloon of thetype generally used for PTA and PTCA procedures. Typically, balloon 114is fixed at its distal end to inner shaft 112 near the catheter-distalend and at its proximal end to outer shaft 115. Balloon 114 is larger indiameter than tube component 116, because balloon 114 must be able toexpand to a larger diameter than tube component 116. Balloon 114 isinflatable through an inflation conduit 123, i.e., the space betweencoaxial inner shaft 113 and outer shaft 115 of the catheter. The distaland proximal ends of balloon 114 are shown in FIGS. 22 and 23 positionedexterior to the distal and proximal ends of tube component 116,respectively, and of a length L-B generally equal to the length L-T ofthe tube component 116. To be compatible with tube component 116illustrated in FIGS. 22 and 23 and described above, balloon 114 isinflatable at deployment to about the diameter of the body vessel inwhich the stent 118 is to be deployed. Balloon 114 may be formed of acompliant or non-compliant material, of the types of compliant materialsdescribed herein above, such as polyethylene or any standard balloonmaterial. Balloon 114 typically has a wall thickness of about0.0007-0.004 inch for example.

A stent for use according to the present invention may be anyconventional type of balloon expandable stent, including stents of thetype used for PTA and PTCA angioplasty procedures, for prostate therapy,and TTS endoscopic catheters for gastrointestinal use. Suitable stentmaterial is biocompatible stainless steel in the form of sheet metal,tube component wire or Nitinol. A preferred stent is described in PCTApplication No. 960 3072 A1, published 8 Feb. 1996, the content of whichis incorporated herein by reference. All such stents are well known inthis art generally and additional examples are described in U.S. Pat.No. 5,507,768 to Lau et al; in U.S. Pat. No. 5,458,615 to Klemm et al;in U.S. Pat. No. 5,226,889 to Sheiban; in U.S. Pat. No. 4,875,480 toImbert; in U.S. Pat. No. 4,848,343 to Wallsten et al, and in U.S. Pat.No. 4,733,665 to Palmaz. Stent 18 as shown in FIGS. 22 and 23 ispositioned on balloon 114, the underlying inflatable tube component 116and the distal end of the catheter. The length L-S of stent 118 is shownas essentially equal or slightly smaller than the length L-T of tubecomponent 116 and is positioned on assembly 110 to be co-extensive withtube component 116. In this position, stent 118 is shown in FIG. 22crimped to its delivery diameter D1, which is about 0.035-0.045 inch forexample.

As discussed above, despite the most careful and firm crimping of stent118 to closely conform to the overall profile of the catheter unexpandedballoon 114 and underlying inflatable tube component 116, there is acertain amount of “recoil” of stent 118 or a tendency of stent 118 toslightly open from a desired hypothetical minimum crimped diameter. Theactual minimum diameter achievable for fully crimped stent 118 onassembly 110 is referred to as the stent 118 delivery diameter D1. Thistendency of stent 118 to open or recoil slightly when crimped onassembly 10 has been characterized as “recoil crimping”. In FIG. 22,inflatable tube component 116 is shown inflated to a diameter which isgenerally sufficient to compensate for any slack or looseness betweencrimped stent 118 and the overall profile of the catheter, theunexpanded balloon 114 and the underlying inflatable tube component 116due to recoil crimping.

FIG. 23 illustrates a side profile section showing a stent delivery anddeployment assembly 110 of this invention with balloon 114 fluidinflated to its fully expanded position. As a result of the fluidinflation of the balloon 114, stent 118 has also been fully expanded toits deployment diameter D2 in which it can be deployed against the wallsof a body vessel in which it is situated.

Tube component 116 may have a shape other than the cylindrical shapedescribed and illustrated with regard to the embodiment shown in FIGS.22 and 23. Further, the tube component may be comprised of more than oneseparately inflatable pouch. For example, as illustrated with regard toFIG. 24, the tube component of an alternative stent delivery anddeployment assembly generally designated 130 can be comprised of threeseparately inflatable pouches 136, 138, 140. The pouches 136, 138, 140are each separately inflatable through their respective inflationconduits 137, 139 141, and each of the pouches 136, 138, 140 can beinflatable to a different extent. The conduits are formed in the wall ofshaft 132 as can be seen in FIGS. 25-27. The stent delivery anddeployment assembly 130 of FIG. 24 is also comprised of a catheterhaving inner shaft 132 and outer shaft 135, a balloon 134, with itsballoon inflation conduit 139 and the balloon terminal cone sections144, and a stent 142. As has been explained above with reference toFIGS. 22 and 23, stent 142 is crimped to closely conform to the overallprofile of the catheter the unexpanded balloon 134 and the underlyinginflatable pouches 136, 138, 140. Even with the most careful and firmcrimping, there is a certain amount of “recoil” of the stent 142 or atendency of stent 142 to slightly open from a desired hypotheticalminimum diameter. In FIG. 24, the first 136 and third 140 pouches areinflated to a slightly larger size than the second pouch 138. Asdiscussed above, the inflation of the pouches 136, 138, 140 to thisconfiguration is generally sufficient to compensate for any slack orlooseness between the crimped stent 142 and the overall profile of thecatheter, the unexpanded balloon 134 and the underlying inflatablepouches 136, 138, 140 due to recoil crimping. Once pouches 136, 138 140have been inflated to the configuration shown in FIG. 24, stent 142 isfirmly secured against axial movement with regard to assembly 130. Thedistal 146 and proximal 148 ends of stent 142 are protected from anypossible unwanted contact with vessel walls during maneuvering, whichhelps to protect the vessel walls from abrasion and also helps toprotect the ends 146, 148 of stent 142 from distortion. Additionally,stent 142 may be of a length such that it fits over pouch 140 and pouch136 as well as over pouch 138.

The method of using the stent delivery and deployment assembly 110 ofthis invention, as shown in FIGS. 22 and 23, is described as follows.The assembly 110 is constructed as described above. Stent 118 iscompressed or crimped onto balloon 114, inflatable tube component 116and the catheter to a delivery diameter D1. This crimping can be donemanually or with the aid of tooling specially designed for the purposeeither by the physician or the manufacturer. In the crimped position,stent we closely conforms to the overall profile of balloon 114,inflatable tube component 116 and the catheter except for the slightslack or looseness due to recoil crimping. Tube component 116 is fluidinflated to the extent necessary to compensate for this slack orlooseness due to recoil crimping. The pressure of force required toinflate tube component 116 to this extent is also referred to assecurement pressure, i.e., the force or pressure needed to secure stent118 in this position. It is to be noted that, since tube component 116is designed and constructed to be capable of fully expanding to no morethan the size necessary to compensate for recoil crimping, there is nopossibility of stent 118 expanding or beginning to open to a largerdiameter. Thus, there is no hazard of stent 118 moving out of itsposition on the catheter during delivery or of becoming separated fromthe catheter within a body vessel. The catheter distal end is deliveredby standard techniques to the deployment site within the body vessel ofinterest. At this point, stent 118 is positioned as required by thephysician and balloon 114 is fluid inflated by standard technique toexpand stent 121 to its deployment diameter D2. During this expansion,stent 118 is expanded to fill the body vessel. Following deployment ofstent 118, balloon 114 and optionally, tube component 116 are deflatedand the assembly 110 is retracted proximally and withdrawn from thebody. If required by the procedure, the site of entry to the body isappropriately closed.

The method of using the stent delivery and deployment assembly 130 ofthis invention, as shown in FIG. 24, is similarly described. Theassembly 130 is constructed as described above. Stent 142 is compressedor crimped to closely conform to the overall profile of balloon 134,inflatable pouches 136, 138, 140 and the catheter except for the slightslack or looseness due to recoil crimping. Pouches 136, 138, 140 areeach fluid inflated to the profile shown in FIG. 24 through separatefluid inflation conduits (not shown) to securement pressure tocompensate for this slack or looseness and to secure stent 142 in thisposition. The overall configuration of pouches 136, 138 140 furtherserves to position stent 142 against axial dislocation during delivery.The catheter is delivered by standard techniques to the deployment sitewithin the body vessel of interest. At this point, stent 142 ispositioned as required by the physician and balloon 134 is fluidinflated by standard technique to expand and deploy stent 142. Followingdeployment of stent 142, balloon 134 and, optionally, pouches 136, 138140 are deflated and the assembly 130 is retracted proximally andwithdrawn from the body. If required by the procedure, the site of entryto the body is appropriately closed.

The inflation tube component provided by this invention maximizes stentsecurement force by optimizing the frictional force between theinflating tube component, the balloon wall and the internal diameter ofthe stent in its reduced crimped delivery diameter. The inflation tubecomponent is more flexible than a solid sheath under the expandableballoon, and thus the entire assembly has greater flexibility. Thisinvention has particular advantages for assemblies in which the stent isprovided for use as pre-crimped to the balloon and underlying catheter,by increasing the shelf life of the pre-crimped assembly. The featuresand principles described for this invention are suitable for use withfixed wire, over-the-wire and single operator exchange assemblies.

FIGS. 28-37 disclose still further embodiments of the securement device.FIGS. 28 and 29 illustrate a side profile section showing an inflationexpandable stent delivery and deployment assembly, generally designated210. Assembly 210 includes a catheter comprised of inner shaft 212 andouter shaft 213 of the coaxial type and an optional retractable deliveryshaft 211 (typically called a guide catheter, shown refracted in FIG.29, an inflation expandable balloon 214, a corrugated/ribbed stentsecurement device 216, optional marker bands 217 and an inflationexpandable stent 218. Any conventional type of catheter may be used,such as a catheter of the type generally used for PTA or PTCAangioplasty procedures, for prostate therapy, and TTS endoscopiccatheters for gastrointestinal use. However, coaxial types as show aremost preferred. The particular catheters 212 and 213 shown are formed ofa biocompatible and hydrophilic compatible material, such as a lubricouspolyimide or poly ethylene. Other suitable materials for the catheters212 and 213 include nylons, urethanes, and polypropylene materialscompatible with coatings such as silicone and/or hydrophilic coatings.In addition to hydrophilic compatible materials, any biocompatiblematerial may be used. For example, polyethylene or polypropylene can becoated with a hydrophilic material to render them hydrophiliccompatible. Suitable catheters for use according to the presentinvention include a number of catheters available from SciMed LifeSystems, Inc., Maple Grove, Minn., the assignee of the presentinvention, such as BANDIT™, COBRA™, VIVA™, VIVA PRIMOT™, MAXXUM™, MAXXUMENERGY™ and RANGER™ catheters.

Securement device 216 is fixed at its distal and/or proximal ends toinner shaft 212 at a position to be encompassed within the distal andproximal ends of the outer balloon 214. According to art-recognizedconvention, the length L-B of the balloon 214 is defined as the lengthof the body portion of the balloon 214, excluding the terminal conesections 220. As seen in FIG. 29, the body portion of the balloon 214 isgenerally cylindrical when in its deployed or inflated condition.Securement device/tube component 216 is illustrated as having terminalsections 221,222. It is to be understood that, according to the presentinvention, either of the terminal sections 220, 222 may be relativelycone shaped, relatively vertical, relatively flat or of any otherconfiguration known to those of skill in this art. A preferred lengthL-T of the tubing 216 is illustrated in FIGS. 28 and 29 as substantiallyequal to the length L-B of balloon 214, and substantially equal to thelength L-S of stent 218. However, according to the present invention,stent 218 should be supported by the underlying tube component 216 for alength sufficient to permit accomplishment of the stated purpose of thetube component 216, to provide a superior securement and protectivesurface for stent 218 to maintain stent 218 in position with assembly210 and to protect the balloon material during loading/crimping. It isalso within the present invention for the tube component 216 to beslightly shorter than stent 218, for example, the distal end 219 ofstent 218 may extend distally beyond the distal end 222 of tubecomponent 216 (not shown), so that the distal end 219 of stent 218 canbe crimped over the distal end 222 of tube component 216 to prevent thedistal end 219 of stent 218 from catching and tending to snag or furtheropen as it is maneuvered within a body vessel. As has been explainedabove, tube component 216 is designed and constricted to have enoughflexibility and have enough volume to no more than is necessary tocompensate for recoil crimping of stent 218 and to closely accommodate(or even slightly over stress) the delivery diameter of stent 218,taking into consideration the thickness of the intervening uninflatedballoon 214. Typically, the tube component 216 will have a consistentfrequency of ribs, but may also vary by having intermittent groups ofribs along the tubing.

The balloon and the crimped stent slightly conform to the undulations ofthe tube component for greater securement, but this conformation is notillustrated.

Tube component 216 may be formed from a thermoplastic material,preferably a low modulus polymer, such as Surlyn™, Pebax and urethane.The device such as polypropylene, low density polyethylene (LDPE), highdensity polyethylene (HDPE), ethylene vinyl acetate (EVA), nylon,polyester and polyethylene terephthalate (“PET”), may be preparedthrough free blowing in a mold or inside a coil. Tubing is extruded withrelatively thin walls and then free-blown in a mold, coil or otherfixture to form the ribs/corrugation.

A balloon 214 for use according to the present invention may be anyconventional balloon for catheter delivery, such as a balloon of thetype generally used for PTA and PTCA procedures. Typically, balloon 214is fixed at its distal end to inner shaft 212 near the catheter distalend and at its proximal end to inner shaft 212, near the distal end ofthe outer shaft 213. Balloon 214. is inflatable through an inflationconduit 223, i.e., the space between coaxial inner shaft 213 and outershaft 213 of the catheter. The distal and proximal ends of balloon 214are shown in FIGS. 28 and 29 positioned exterior to the distal andproximal ends of tube component 216, respectively, and of a length L-Bgenerally equal to the length L-T of the tube component 216. To becompatible with the tube component 216 illustrated in FIGS. 28 and 29and described above, balloon 214 is inflatable at deployment to aboutthe diameter of the body vessel in which the stent 218 is to bedeployed. Balloon 214 may be formed of a compliant or non-compliantmaterial, such as polyethylene or any standard balloon material.Compliant materials include low pressure, relatively soft or flexiblepolymeric materials, such as thermoplastic polymers, thermoplasticelastomers, polyethylene (high density, low density, intermediatedensity, linear low density), various co-polymers and blends ofpolyethylene, ionomers, polyesters, polyurethanes, polycarbonates,polyamides, poly-vinyl chloride, acrylonitrile-butadiene-styrenecopolymers, polyether-polyester, copolymers, and polyetherpolyamidecopolymers. Suitable materials include a copolymer polyolefin materialavailable from E.I. DuPont de Nemours and Co. (Wilmington, Del.), underthe trade name Surlyn™ Ionomer and a polyether block amide availableunder the trade name PEBAX™. Non-compliant materials include relativelyrigid stiff high pressure polymeric materials, such as thermoplasticpolymers and thermoset polymeric materials, poly(ethylene terephthalate)(commonly referred to as PET), polyimide, thermoplastic polyimide,polyamides, polyesters, polycarbonates, polyphenylene sulfides,polypropylene and rigid polyurethanes, or combinations thereof. Theballoon 214 typically has a wall thickness of about 0.0007-0.004 inchfor example.

A stent for use according to the present invention may be anyconventional type of balloon expandable stent, including stents of thetype used for PTA and PTCA angioplasty procedures, for prostate therapy,and TTS endoscopic catheters for gastrointestinal use. Suitable stentmaterial is biocompatible stainless steel in the form of sheet metal,tube component wire or Nitinol. A preferred stent is described in PCTApplication No. 960 3072 A1, published 8 Feb. 1996, the content of whichis incorporated herein by reference. All such stents are well known inthis art generally and additional examples are described in U.S. Pat.No. 5,507,768 to Lau et al; in U.S. Pat. No. 5,458,615 to Klemm et al;in U.S. Pat. No. 5,226,899 to Sheiban; in U.S. Pat. No. 4,875,480 toImbert; in U.S. Pat. No. 4,848,343 to Wallsten et al; and in U.S. Pat.No. 4,733,665 to Palmaz. Stent 218 as shown in FIGS. 28 and 29 ispositioned on balloon 214, which is over the underlying tube component216, at the distal end of the catheter. The length L-S of stent 218 isshown as essentially equal or slightly smaller than the length L-T oftube component 216 and is positioned on assembly 210 to be coextensivewith tube component 216. In this position, stent 218 is shown in FIG. 28crimped to its delivery diameter D1, which is about 0.035-0.45 inch forexample.

As discussed above, despite the most careful and firm crimping of stent218 to closely conform to the overall profile of the catheter unexpandedballoon 214 and underlying tube component 216, there is a certain amountof “recoil” of stent 218 or a tendency of stent 218 to slightly openfrom a desired hypothetical minimum crimped diameter. The actual minimumdiameter achievable for fully crimped stent 218 on assembly 210 isreferred to as stent 218 delivery diameter D1. This tendency of stent218 to open or recoil slightly when crimped on assembly 210 has beencharacterized as “recoil crimping”. In FIG. 28, tube component 216 isshown inflated to a diameter which is generally sufficient to compensatefor any slack or looseness between crimped stent 218 and the overallprofile of the catheter, the unexpanded balloon 214 and the underlyingtube component 216 due to recoil crimping.

FIG. 29 illustrates a side profile section showing a stent delivery anddeployment assembly 210 of this invention with balloon 214 fluidinflated to its fully expanded position. As a result of the fluidinflation of the balloon 214, stent 218 has also been fully expanded toits deployment diameter D2 in which it can be deployed against the wallsof a body vessel in which it is situated.

FIG. 30 illustrates the preferred configuration of the tube component216. The tube component has a plurality of ribs 230 and is configured ina corrugated or accordion fashion. The ends of the tube component 216,222 and 221, are substantially rib-free so as to provide a flat surfaceto receive an adhesive and thereby bond to the inner shaft 212.Preferable adhesives include cyanoacrylates such as Loctite 4061/4011 orurethanes, such as H.B. Fuller 3507/3506. The tube component may also beheat bonded to the inner shaft. The ribs may vary in frequency andspacing.

Tube component 216 may have different configurations in otherembodiments, as shown in FIGS. 31-33. The tube component 216 may becomprised of more than one piece of corrugated tubing (FIG. 31), asmaller single piece (FIG. 32) or one single piece of tubing sectionedinto a plurality of ribbed sections, wherein the tubing is adhered tothe inner shaft 212 in more than two locations (FIG. 33).

FIG. 31 shows two pieces of tubing component 216 a, 216 b. Both piecesare adhered to inner shaft 212 at adhesion points 232. FIG. 32 disclosesan embodiment which comprises one smaller piece of tube component 216which is adhered to inner shaft 212 at adhesion points 232. FIG. 33discloses an embodiment which comprises one tube component 216 which hasinterrupted ribbed sections 234 adhered to the inner shaft 212.

FIGS. 34 and 35 illustrate an alternative embodiment in which the tubingcomponent is inflatable to increase the securement pressure on theinside of balloon 214 when the stent is crimped onto the balloon so asto negate additional recoiling. The full expansion of the tube component216 should only be slightly greater than the diameter of the inside ofthe balloon 214 when the stent 218 is fully crimped onto the balloon214.

In FIG. 34, the inflating fluid comes through the guide wire lumen 212under pressure from the proximal end or the distal end of the guide wirelumen 212, preferably via a syringe, and fills the tubing component 216through a one-way valve 247 (preferably resisting up to about 4 atm) inthe inner catheter 212.

In FIG. 35, the tubing component 216 is inflated via an additional lumen242 which extends from the proximal end of the catheter along the guidewire lumen 240, much the same as any inflating lumen incorporated toinflate a balloon.

In an alternative embodiment, as shown in FIG. 36, socks or sleeves 251may be incorporated to stretch over the ends of the stent to preventsnagging and to secure the stent onto the balloon. Such sleeves aredemonstrated in U.S. application Ser. No. 08/702,149, filed Aug. 23,1996, and Ser. No. 08/701,979, filed Aug. 23, 1996, which areincorporated in their entirety herein by reference.

In still another embodiment, as shown in FIG. 37, the tubing component216 is slidable axially along the inner shaft 212 and is connected to aretracting wire 250 such that the tubing component may be retracted intothe outer shaft 213 after the balloon has been inflated to reduce theprofile of the balloon 214 when the catheter is removed. The tubingcomponent, since it is not adhered to the inner shaft 212 in thisembodiment, should fit tightly enough on the inner shaft to stay inplace, but not too tightly so that it may be retracted by pulling on theretracting wire 250.

The method of using the stent delivery and deployment assembly 210 ofthis invention, as shown in FIGS. 1 and 2, is described as follows. Theassembly 210 is constructed as described above. Stent 218 is compressedor crimped onto balloon 214, tube component 216 and the catheter to adelivery diameter D1. This crimping can be done manually or with the aidof tooling specifically designed for the purpose either by the physicianor the manufacturer. In the crimped position, stent 218 closely conformsto the overall profile of balloon 214, tube component 216 and thecatheter except for the slight slack or looseness due to recoilcrimping. Tube component 216 is flexible enough to slightly collapseduring crimping and rebound to the extent necessary to compensate forthe slack or looseness due to recoil crimping, thus securing the stent.As a result, the stent does not move out of its position on the catheterduring delivery or become separated from the catheter within a bodyvessel. The catheter distal end is delivered by standard techniques tothe deployment site within the body vessel of interest. At this point,stent 218 is positioned as required by the physician and balloon 214 isfluid inflated by standard technique to expand stent 218 to itsdeployment diameter D2. During this expansion, stent 218 is expanded tofill the body vessel. Following deployment of stent 218, balloon 214 isdeflated and the assembly is retracted proximally and withdrawn from thebody. If required by the procedure, the site of entry to the body isappropriately closed.

The tube component provided by this invention increases stent securementforce by increasing the frictional force between the tube component, theballoon wall and the internal diameter of the stent in its reducedcrimped delivery diameter. The tube component is more flexible than asolid sheath under the expandable balloon, and thus the entire assemblyhas greater flexibility. This invention has particular advantages forassemblies in which the stent is provided for use as pre-crimped to theballoon and underlying catheter, by increasing the shelf life of thepre-crimped assembly. The tube component also protects the balloonmaterial during crimping by acting as a buffer between the balloonmaterial and whatever may be mounted on the inner shaft, such as markerbands 217. The features and principles described for this invention aresuitable for use with fixed wire, over-the-wire and single operatorexchange assemblies.

FIGS. 38-46 disclose alternative embodiments of the securement device.FIG. 38 shows a stent delivery and deployment assembly generallydesignated 310. A catheter 312 has a collar 314 coaxially mounted at thecatheter distal end portion 316. An uninflated balloon 318 is coaxiallymounted on catheter 312 over collar 314. An unexpanded stent 320 iscoaxially mounted on the balloon 318 abutting but not overlying collar314. A cup 322 coaxially overlies the stent proximal end portion 324.Cup 322 may be elastomeric or rigid, preferably elastomeric. Cup 322 isover-expanded over the stent 320, so that recoil of the cup 322 issufficient to secure stent 320 in place and prevent it from being pulledoff of the assembly 310 distally or proximally as assembly 310 isdelivered to a deployment site in a body vessel. Cup 322 also protectsthe proximal end of stent 324 from inadvertently catching on anatomicalstructures or other things during maneuvering within the body or duringloading and other handling. The ends of the stent may axially protrudeand should be protected during maneuvering of stent 320 to keep stent 18on assembly 310 in its contracted configuration and to maintain thestructural integrity of stent 320. Collar 314 abuts the stent distal end326 without underlying stent 320. The position of cup 322 overlyingstent 320 and containing stent 320 against collar 314 increases thesecurement force maintaining stent 320 in its axial and radial positionon catheter 12. FIG. 40 is similar to FIG. 38, showing a bulge 28beneath the uninflated balloon 318 at catheter distal end 316.

Any of the various types of known stents may be used in the deliverysystem of this invention, even self-expanding stents which are partlyballoon-expandable may be used, the balloon initiating release of thestent and/or finally seating the stent after self-expansion. However,ordinary balloon expandable stents are preferred and aforenoted.

FIG. 39 shows another stent delivery and deployment assembly generallydesignated 330. A catheter 332 has a collar coaxially mounted as amounting ring 334 on the catheter. An uninflated balloon 338 iscoaxially mounted on catheter 332 over mounting ring 334. An unexpandedstent 340 is coaxially mounted on balloon 338 overlying the mountingring 34. A cup 342 overlies the stent proximal end portion 344 to securethe stent 340 in place and prevent it from being pulled off of assembly330 distally or proximally, as assembly 330 is delivered to a deploymentsite in a body vessel. Cup 342 also protects the proximal end of stent40 from inadvertently catching on anatomical structures duringmaneuvering within the body. The position of cup 342 overlying stent 340together with the closer positioning of mounting ring 334 as compared toFIG. 38 increases the securement force maintaining stent 340 in itsaxial and radial position on catheter 332. The closer the mounting ring334 is positioned to cup 342 the more securely the stent is held inplace and interlocked between this cup and ring. When used inconjunction with mounting ring 334, cup 342 will also prevent the stentproximal segment 344 from opening up, i.e., increasing its diameter, andwill keep the stent 340 locked onto the mounting ring 334. This willprevent stent 340 from moving on the catheter distally as well asproximally. This cup does not have to be an elastomer, but may besufficiently rigid to prevent the stent 340 from expanding.

Cups 322, 342 of FIGS. 38-40 release stents 320, 340 when balloons318,338 are inflated during deployment. Cups 322,342 can, for example,flare radially outward as illustrated with reference to FIG. 41, rollaxially away from stents 320, 340 as illustrated with reference to FIG.42, or slide axially away from stents 320, 340 as illustrated withreference to FIGS. 43 and 44. Also, the cups may be formed with axialareas of weakness which split on balloon inflation, as described in theaforenoted Savin patent.

FIG. 41 shows an assembly generally designated 310 as shown in FIGS. 38and 36 with balloon 318 inflated and stent 320 expanded, showing the cup322 end portion flared to release stent 320. As noted above, cup 322 maybe elastomeric or rigid. The dimension L is short enough and thematerial of cup 322 is sufficiently elastic so that cup 322 flares outand is no longer in contact with stent 320 when balloon 318 is inflatedand the stent 320 expanded for deployment.

FIG. 42 shows an assembly generally designated 310, as shown in FIGS. 38and 36, with balloon 318 inflated and stent 320 expanded, showing cup322 end portion rolled proximally to release the stent 320. As notedabove, the cup 322 may be elastomeric to facilitate rolling. The cup mayalso accordion or bunch up on itself to release the stent.

FIGS. 43 and 44 show yet another stent delivery and deployment assemblygenerally designated 350. The catheter 352 has a coaxial collar 354formed integrally with catheter 352 at the catheter distal end 356. Aballoon 358 is coaxially mounted on catheter 352, overlying collar 354.In FIG. 43, balloon 358 is coaxially mounted on catheter 352, overlyingcollar 354. In FIG. 43, balloon 358 is shown as uninflated, with anunexpanded stent 360 mounted on balloon 358 abutting collar 354, and acylindrical cup in the form of sleeve 362 overlying the stent proximalend portion 364. FIG. 44 shows the assembly 350 of FIG. 43 with balloon358 inflated and stent 360 released and expanded. Sleeve 362 isdesigned, constructed and adapted so that, as balloon 358 and stent 360are enlarged, the sleeve portion 366 gathers or moves proximally torelease stent 360. The increasing angle of the balloon 358 cone (thetapered end sections of balloon 358) during inflation push sleeve 362axially away from stent 360. This can be done by shaping sleeve 362 withpreformed accordion pleats 368. Sleeve 362 may also be formed so thatthe portion detaining (that is, abutting or overlying) stent 360 is ofthicker or more rigid material than the portion of sleeve 362 axiallydistant from stent 360. Materials which may be used to provide theforegoing function are silicones, urethanes and the like as well asother elastomers, for example. A rigid sleeve carried on the catheterfor sliding movement may also be used. Sleeves may be included at theproximal and distal end of the stent.

FIG. 45 shows still another stent delivery and deployment assemblygenerally designated 370. A catheter 372 has two collars 374 formedintegrally with catheter 372 and spaced from each other on the catheterdistal end portion. A balloon 378 is coaxially mounted on the catheter372, overlying the collars 374. The balloon 378 is shown as uninflatedwith an unexpanded stent 380 mounted on balloon 378 abutting both of thecollars 374. It can be seen that the distance between the collars 374 isto be chosen to closely accommodate stent 380 in its fully contractedposition about the balloon 378 and underlying catheter 372. A cup 382overlies the stent proximal end portion 384 and the underlying proximalcollar 374. Cup 382 will deploy during balloon 378 inflation in themanner described above with reference to FIGS. 41-44.

FIG. 46 shows even another stent delivery and deployment assemblygenerally designated 390. The uninflated balloon 398 is shown coaxiallymounted on a catheter 392 at the catheter distal end portion. Anunexpanded stent 400 is coaxially mounted on balloon 398. A pair of cups402 overlap the ends of the stent 400 ends. A mounting cylinder 404 iscarried by the catheter shaft 392.

The Figure also illustrates cups at both ends of the stent, anarrangement which may be used in all the foregoing embodiments.

The cups or sleeves used in the various embodiments of this inventioncan be of elastomeric or rigid material to contain one or both ends ofthe stent. In preferred embodiments of this invention the cups are usedin conjunction with one or more stent collars positioned under theballoon. The collar may be formed as a ring, to abut the end of thestent, to lie under the stent and the intervening balloon, or as acylinder, to lie under essentially the entire length of the stent andthe intervening balloon. The stent detainment according to the presentinvention offers increased stent securement, particularly on pre-mounteddelivery systems. The cups and sleeves illustrated in the variousembodiments of this invention can be secured to the catheter, as byadhesive or thermal bonding, or they may be sliding cups or sleeves.When the cups are freely sliding on the catheter, they should always beused directly over a collar so that there is a friction fit between thecup and the stent.

A method for delivering and deploying a stent using an assemblyaccording to the present invention is described as follows: A catheteris provided as described above with reference to any of FIGS. 38-40, 43and 45. At least one collar is coaxially mounted at the catheter distalend. As discussed above, the collar may be a separate element affixed tothe catheter or the collar and catheter may be formed together as asingle element. The collar may be positioned abutting an end of thestent. The collar may be a mounting ring, may be positioned under thestent or underlying the balloon. The collar may be a cylinderessentially coextensive in length with the stent and underlying theballoon. A fluid expandable balloon is coaxially mounted over the collaron the catheter distal end. A stent is provided which is inflationexpandable from a reduced to an enlarged condition. The stent, in itsreduced condition, is coaxially mounted on the balloon so that at leastan end portion of the stent overlies the balloon. A cup is providedwhich has first and second end portions. The cup is in an expanded formand also has a retracted form. The expanded cup is coaxially mounted onthe catheter at the distal end portion so that the cup first end portiondetains the stent end portion. The cup first end portion detains thestent end portion by overlying the stent end portion, or by closelyaccommodating the stent against the collar without overlying the stentend portion. The cup is then contracted about the catheter and the stentend portion to fix the stent to the catheter. The cup and collarcooperate to retain the stent on the catheter in its reduced condition.The assembly is then maneuvered by the physician through a body vesselby methods known per se to reach a pre-selected deployment site. Thesurgeon can determine when the assembly has reached the deployment siteby means which are themselves known per se. For example, the assemblymay be provided with radiopaque marking bands at either end of thestent, or the cups or the collars or both may be made of radiopaquematerial. Once the surgeon determines that the stent has been correctlypositioned at the desired site, the balloon is inflated to expand thestent to its enlarged condition. Inflation of the balloon expands thestent and the stent is released from the cup or cups. As has beendiscussed above, the cups may deploy to release the stent in a number ofways, dependent on the construction and materials of the cup or cups.The cup may flare or enlarge radially following the increasing angle ofthe balloon cones. The cup may roll axially away from the stent. Theportion of the cup axially distant from the stent may accordion back onitself. The cup may slide axially. The cup may accordion or buckle. Ifthe cup is not fixed to the catheter, but is freely slidable on thecatheter, the cup may slide axially away from the stent. Afterdeployment of the stent, the balloon, according to previously knownprocedures, is deflated and the assembly is withdrawn proximally fromthe body vessel. Any incision made to allow access from the assembly isappropriately closed.

FIGS. 47-56 illustrated alternative embodiments of securement devices.Referring to FIGS. 47 and 48 a stent delivery system generally indicatedat 410 includes a balloon catheter 412 having a balloon 414 on a distalend portion generally indicated at 416. FIG. 47 shows a proximal portionof the catheter at 412 a and a distal portion 412 b in enlarged view.FIG. 48 shows the distal end portion 416 in an even more enlarged view.The illustrative catheter 412 is of the type known as an over the wirecatheter. However, other types of catheters may be used, such as rapidexchange/single operator exchange and fixed wire types. The balloon 414is fixed to the catheter 412 by standard means. The balloon is shown inits contracted state in FIGS. 47 and 48. A stent 418 is fixed about theballoon by crimping it thereto. The stent has a larger expanded diameterwhich is obtained when the balloon is expanded in the known manner. Thatis, the stent is released from the catheter upon expansion of theballoon when placed in a vessel. When the balloon is then deflated,removal of the balloon and catheter may be accomplished while leavingthe stent in place.

As is known in the art the balloon is either bonded at its ends byadhesive 420 and 422, respectively to the outer member 424 of thecatheter and to the inner member 426 of the catheter in the manner asshown, or is made one-piece with the outer member as is known in theart. The catheter balloon may be inflated by fluid (gas or liquid) froman inflation port extending from a lumen 428 contained in the cathetershaft and opening into the balloon as shown, or by other knownarrangements, depending on the design of the catheter. The details andmechanics of balloon inflation and specific overall catheterconstruction will vary according to the particular design involved inany given instance, and are known in the art per se. All variations areacceptable for use with this invention.

Any balloon expandable stent may be used with this invention. Many areknown in the art including plastic and metal stents. Some are more wellknown such as the stainless steel stent shown in U.S. Pat. No.4,735,665; the wire stent shown in U.S. Pat. No. 4,950,227; anothermetal stent shown in European Patent Application No. EPO 707 837 A1 andthat shown in U.S. Pat. No. 5,445,646. All of these patents areincorporated herein by reference. Also, shape memory metal stents may beused. As already indicated the stent of PCT Application 960 3092 A1 isparticularly preferred.

The stent is typically about 16 mm long, while the balloon may be 20 mmlong. These dimensions, however, are merely representative forillustrative purposes only and are not meant to be limiting. The stentis positioned over the balloon portion of the dilatation catheter andgently crimped onto the balloon either by hand or with a tool such as apliers or the like to be mounted for delivery as shown in FIGS. 47 and48. The crimping may be accomplished by either the manufacturer or thephysician.

In accordance with one embodiment of this invention, a mounting bodies430, seen in FIGS. 47 and 48 are included inside balloon 414 to providea cushion and/or substrate of enlarged diameter relative to the shaft tosupport and hold the stent and secure it during crimping and thedelivery procedure. The mounting bodies are preferably located in thebody portion of the balloon.

In the embodiment shown, mounting bodies 430 are ring-like in form andare mounted on inner lumen 426, providing an enlarged area or portionfor receiving the balloon and stent when the latter is crimped. Markerbands 432 and 434 may also be included on inner 426 as shown. Anyradiopaque material such as gold is useful for this purpose. Although,the material of the mounting bodies may be hard, it is preferably of anythermoplastic elastomer having elastic or deformable properties, morepreferably of a relatively resilient elastomer material, e.g., silicone,preferably a lower durometer silicone, or polyurethane, such asTecothane 1055D. A deformable thermoplastic material such as highdensity polyethylene (HDPE) may be used. Any deformation of resilientmaterial of the mounting body when the stent/balloon is crimped to itcauses a radial outward force on the stent/balloon increasing thefriction therebetween despite a recoil of the stent.

The stent is also fixed in position by two overlying retaining sleeves436 and 438. Sleeves 436 and 438 are formed of polyurethane, preferablyTecothane 1055D, and are axially fixed on catheter 412 by adhesive plugs440 and 442 of urethane adhesive. The plugs of adhesive may be taperedto the catheter as shown to facilitate movement of the catheter in avessel. The sleeves overlap the marginal end portions of stent 418 asshown.

A lubricating solution such as silicone fluid may be used betweenballoon 414 and sleeves 436 and 438 and thereon to facilitate release ofstent 418 from the sleeves.

During delivery, the balloon catheter is advanced through and positionedin a patient's vasculature so that the stent is adjacent to the portionof the vessel where treatment is to take place. The balloon is inflatedto expand the stent to an enlarged diameter. At this time, expansion ofthe balloon causes the end margin of the sleeves to slide axially fromover the stent thereby releasing the ends of the stent from thecatheter. Various forms of retraction of sleeves 436 and 438 are shownin FIGS. 49-52. These figures illustrate the configuration of thesleeves 436 and 438 in their retracted state after the balloon 414 hasbeen fully expanded. Only the distal sleeve 438 is shown. FIG. 49illustrates the preferably refraction configuration. To promote easierretraction sleeves are coated with silicone. The sleeves are preferablyadhered to the outer shaft 424 and the inner shaft 426 at point 440,442, but may be adhered further up the waste 441 of the balloon. Therefraction configurations may be controlled by either pre-creasing thesleeves or adhering the sleeve to a point further up on the waist of theballoon. The sleeves have a tendency of folding at a pre-fold crease orat the point of adherence. A preferred cone angle of 45.degree, for theballoon is shown in FIG. 52, which shows an expanded balloon 414 andretracted sleeves 436,438. When the stent has reached the desireddiameter, the balloon is deflated so that the catheter may be removedleaving the stent in place.

A modified 439 sleeve configuration is shown in FIG. 53 in stepped form43 having a large diameter at 444 in one section 446 and a smalldiameter 445 in a second section 450.

FIGS. 54-56 show alternative embodiments of the invention. Specifically,alternative positioning and number of mounting bodies 430. These figuresshow an unexpanded balloon having the mounted bodies 430 within theballoon. They are meant to illustrate essentially the same structure asshown in FIG. 448 differing only in the number and positioning of themounted bodies 430. In the embodiment shown in FIG. 54, the ring-likemounting body 430 is singular. Another similar version is shown in FIG.55 which includes three ring-like mounting bodies 430. The embodimentshown in FIG. 56 includes four ring-like mounting bodies 430.

It should be understood that the various elements and materials of allembodiments could be utilized in each of the other embodiments, ifdesired.

The above Examples and disclosure are intended to be illustrative andnot exhaustive. These examples and description will suggest manyvariations and alternatives to one of ordinary skill in this art. Allthese alternatives and variations are intended to be included within thescope of the attached claims. Those familiar with the art may recognizeother equivalents to the specific embodiments described herein whichequivalents are also intended to be encompassed by the claims attachedhereto.

What is claim is:
 1. A medical device, comprising: an elongate shaftincluding a first tubular member and a second tubular member; a ballooncoupled to the shaft; a first member coupled to the first tubular memberand positioned within the balloon, the first member including a distalstop with a tapered distal portion; wherein the distal stop includes aproximal end face extending substantially perpendicular to alongitudinal axis of the elongate shaft; a second member coupled to thefirst tubular member and positioned within the balloon, the secondmember having a distal end disposed proximal of the distal stop; and amedical implant coupled to the shaft and positioned adjacent to theballoon.
 2. The medical device of claim 1, wherein the first tubularmember is an inner tubular member and wherein the second tubular memberis an outer tubular member.
 3. The medical device of claim 2, wherein aninflation lumen is defined between the inner tubular member and theouter tubular member, the inflation lumen being in fluid communicationwith the balloon.
 4. The medical device of claim 3, wherein the balloonhas a proximal portion coupled to the outer tubular member and whereinthe balloon has a distal portion coupled to the inner tubular member. 5.The medical device of claim 4, wherein the proximal portion of theballoon is adhesively bonded to the outer tubular member.
 6. The medicaldevice of claim 4, wherein the distal portion of the balloon isadhesively bonded to the inner tubular member.
 7. The medical device ofclaim 1, wherein the second member is a support member configured tosupport the medical implant.
 8. The medical device of claim 1, whereinthe second member includes a distal portion having a substantiallyconstant outer diameter.
 9. The medical device of claim 1, wherein thefirst member and the second member are longitudinally spaced from eachother.
 10. The medical device of claim 1, wherein the medical implantincludes a stent.
 11. The medical device of claim 1, wherein the medicalimplant is configured to be expanded by expanding the balloon.
 12. Themedical device of claim 1, wherein the first member, the second member,or both include a radiopaque marker.
 13. A system for delivering amedical device, the system comprising: a catheter shaft, the cathetershaft including an inner tubular member and an outer tubular member; aballoon coupled to the catheter shaft; a distal stop including a tapereddistal portion attached to the inner tubular member and positioned atleast partially underneath the balloon; wherein the distal stop includesa proximal end face extending substantially perpendicular to alongitudinal axis of the catheter shaft; a proximal member attached tothe inner tubular member and positioned underneath the balloon, theproximal member having a distal end disposed proximal of the distalstop; and a cardiovascular implant disposed along the catheter shaft,the cardiovascular implant being configured to shift between a firstconfiguration and an expanded configuration.
 14. The system of claim 13,wherein an inflation lumen is defined between the inner tubular memberand the outer tubular member, the inflation lumen being in fluidcommunication with the balloon.
 15. The system of claim 14, wherein theballoon has a proximal portion coupled to the outer tubular member andwherein the balloon has a distal portion coupled to the inner tubularmember.
 16. The system of claim 13, wherein the proximal member includesa distal region having a substantially constant outer diameter.
 17. Thesystem of claim 13, wherein the distal stop and the proximal member arelongitudinally spaced from each other.
 18. The system of claim 13,wherein the cardiovascular implant includes a stent.
 19. The system ofclaim 13, wherein the cardiovascular implant is configured to beexpanded by the balloon.
 20. The system of claim 13, wherein the distalstop, the proximal member, or both include a radiopaque marker.
 21. Amedical device for implanting a medical implant, the medical devicecomprising: a catheter shaft, the catheter shaft including an innertubular member and an outer tubular member; a balloon attached to thecatheter shaft; wherein a proximal portion of the balloon is coupled tothe outer tubular member and a distal portion of the balloon is coupledto the inner tubular member; wherein an inflation lumen is definedbetween the inner tubular member and the outer tubular member, theinflation lumen being in fluid communication with the balloon; wherein abody portion of the balloon extends over an implant receiving region ofthe inner tubular member; a distal stop including a tapered distalportion attached to the inner tubular member adjacent to the implantreceiving region; wherein the distal stop includes a proximal end faceextending substantially perpendicular to a longitudinal axis of thecatheter shaft; wherein at least a portion of the distal stop isdisposed within the balloon; a proximal member attached to the implantreceiving region and positioned between the implant receiving region andthe body portion of the balloon, the proximal member having a distal enddisposed proximal of the distal stop; and an implantable endoprosthesisdisposed along the catheter shaft, the implantable endoprosthesis beingconfigured to be received along the implant receiving region.
 22. Themedical device of claim 21, wherein the proximal member includes adistal region having a substantially constant outer diameter.
 23. Themedical device of claim 21, wherein the distal stop and the proximalmember are longitudinally spaced from each other.
 24. The medical deviceof claim 21, wherein the implantable endoprosthesis includes a stent.25. The medical device of claim 21, further comprising a radiopaquemarker coupled to the inner tubular member.
 26. A system for deliveringan implantable medical device, the system comprising: a catheter shaft,the catheter shaft including an inner tubular member and an outertubular member; wherein the inner tubular member has a distal end thatextends distally beyond a distal end of the outer tubular member;wherein the inner tubular member defines a guidewire lumen; a balloonattached to the catheter shaft, the balloon being configured to shiftbetween a collapsed configuration and an expanded configuration; whereina proximal portion of the balloon is coupled to the outer tubular memberand a distal portion of the balloon is coupled to the inner tubularmember; wherein an inflation lumen is defined between the inner tubularmember and the outer tubular member, the inflation lumen being in fluidcommunication with the balloon; wherein a body portion of the balloonextends over an implant receiving region of the inner tubular member; adistal stop attached to the inner tubular member at a position adjacentto the implant receiving region, the distal stop being disposed at leastpartially between the balloon and the inner tubular member; wherein atleast a section of the distal stop is tapered; a proximal memberattached to the implant receiving region and being positioned betweenthe implant receiving region and the body portion of the balloon;wherein the distal stop is axially spaced from the proximal member; afirst radiopaque marker disposed along the implant receiving region andpositioned adjacent to the distal stop; a second radiopaque markerdisposed along the implant receiving region and positioned adjacent tothe proximal member; wherein the first radiopaque marker is axiallyspaced from the second radiopaque marker; and an implantableendoprosthesis disposed along the catheter shaft and configured to bereceived along the implant receiving region, the implantableendoprosthesis being configured to be expandable by the balloon.